Venous ThromboembolismPhase 4NCT07189897
Apixaban or Enoxaparin After Head and Neck Cancer Surgery
A Phase 4 study testing Enoxaparin and Apixaban in people with Venous Thromboembolism and Head and Neck Cancer, run by Kiranya Arnold at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will also learn about side effects of both medicines. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Venous Thromboembolism, Head and Neck Cancer
- What is being tested?
- Enoxaparin and Apixaban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- Provide signed and dated informed consent.
- Be willing and able to comply with study procedures and follow-up.
- Be 18-89 years old (male or female).
- Have a negative pregnancy test within 24 hours before surgery (if woman of childbearing potential).
- Have biopsy-proven head and neck cancer, or a suspected cancer awaiting tissue diagnosis (can be confirmed by frozen section at surgery).
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- Be scheduled for major inpatient or outpatient oncologic head and neck surgery (defined as >45 minutes operative time).
- Be an appropriate surgical candidate (adequate performance status).
- Eligible diagnoses include (not limited to):
- Squamous cell carcinoma of oral cavity, hypopharynx, larynx, nasal cavity
- Malignancies from major salivary glands
- Non-melanoma skin cancers (squamous cell, basal cell, Merkel cell carcinoma)
- Unknown primary tumors of head and neck
Who cannot join
- Participants cannot:
- Lack a tissue diagnosis of head and neck cancer during the study period.
- Have one of these conditions instead of eligible cancer: Benign disease; Primary thyroid cancer (lower VTE risk); Lymphoma (not primarily surgical); or Melanoma
- Fail to undergo definitive head and neck oncologic surgery (e.g., only diagnostic biopsy).
- Have surgery limited to tissue diagnosis only (e.g., direct laryngoscopy, excisional lymph node biopsy).
- Be unable (patient or caregiver) to administer the study drug.
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- Have a positive pregnancy test on the day of surgery.
- Have a known history of prior DVT or PE (since extended anticoagulation would be indicated).
- Have hereditary or acquired bleeding/clotting disorders.
- Have severe renal impairment (CrCl <30 mL/min).
- Have conditions that, in the investigator's judgment, make study participation unsafe or confound results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SUNY Upstate
Syracuse, New York, 13210
Laine Abernathy, 315-464-5980, abernatL@upstate.edu
About this study
Official title: An Open-label Pilot Study to Evaluate Medication Satisfaction With Apixaban Versus Enoxaparin for Thrombosis Prevention After Head and Neck Cancer Surgery
The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will also learn about side effects of both medicines.
The main questions it aims to answer are:
Read more
Can apixaban be used safely instead of enoxaparin to prevent blood clots after surgery? Do patients find apixaban easier or more satisfying to take than enoxaparin? How well do patients follow the treatment plan with each medicine?
Researchers will compare 2 groups:
One group will take apixaban (a pill taken twice a day) for 10 days after surgery.
The other group will take enoxaparin (a shot given once a day) for 10 days after surgery.
Participants will:
Take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total Keep a medication diary and bring back unused medicine so the study team can check adherence Complete short surveys about satisfaction with their medicine Have an ultrasound of their legs to check for blood clots 11-14 days after surgery Return for follow-up visits about 40 days and 80 days after surgery for safety checks
How long will participation last? About 4 months from surgery through the last follow-up visit.
- Conditions
- Venous Thromboembolism, Head and Neck Cancer
- Being tested
- Enoxaparin, Apixaban
- Keywords
- surgery, apixaban, enoxaparin, thrombosis
- Medical subject headings
- Venous Thromboembolism, Head and Neck Neoplasms, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
For DVT prophylaxis
ApixabanDrug
For DVT prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Control: Enoxaparin | Active comparator | 40 mg subcutaneous enoxaparin given once daily for DVT prevention. Receives: Drug: Enoxaparin |
| Experimental: Apixaban | Experimental | 2.5 mg oral apixaban given twice daily for DVT prevention. Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study enrollment rate.
Enrollment rate will be calculated as the number of participants enrolled, divided by the number of eligible participants, multiplied by 100%.
Measured: From study start until target enrollment is reached (up to 24 months).
Secondary outcomes (2)
Medication satisfaction.
Mean Anti-Clot Treatment Scale (ACTS) score. The ACTS comprises two primary subscales: ACTS Burdens and ACTS Benefits. The ACTS scores range from 12 to 60, but are often reverse-coded so that higher values indicate greater satisfaction. The ACTS Benefits scores range from 3 to 15, where higher scores reflect higher satisfaction.
Measured: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Medication satisfaction.
Mean Treatment Satisfaction Questionnaire for Medication (TSQM) - 1.4 score. TSQM 1.4 has four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Each domain is scored separately on a scale from 0 to 100, where higher scores indicate greater satisfaction.
Measured: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiranya Arnold
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Upstate Medical University
- Responsible party
- Sponsor-investigator, Kiranya Arnold, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189897
- Sponsor's protocol ID
- 2225826-3
- Status last verified
- Oct 2025
- First submitted
- 13 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Study to Evaluate Medication Satisfaction With Apixaban Versus Enoxaparin for Thrombosis Prevention After Head and Neck Cancer Surgery
- ClinicalTrials.gov ID
- NCT07189897
- Acronym / sponsor ID
- 2225826-3
- Conditions
- Venous Thromboembolism, Head and Neck Cancer
- Keywords
- surgery, apixaban, enoxaparin, thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Kiranya ArnoldUniversity, hospital or other
- Collaborators
- State University of New York - Upstate Medical University
- Study start
- Oct 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will also learn about side effects of both medicines.
The main questions it aims to answer are:
Can apixaban be used safely instead of enoxaparin to prevent blood clots after surgery? Do patients find apixaban easier or more satisfying to take than enoxaparin? How well do patients follow the treatment plan with each medicine?
Researchers will compare 2 groups:
One group will take apixaban (a pill taken twice a day) for 10 days after surgery.
The other group will take enoxaparin (a shot given once a day) for 10 days after surgery.
Participants will:
Take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total Keep a medication diary and bring back unused medicine so the study team can check adherence Complete short surveys about satisfaction with their medicine Have an ultrasound of their legs to check for blood clots 11-14 days after surgery Return for follow-up visits about 40 days and 80 days after surgery for safety checks
How long will participation last? About 4 months from surgery through the last follow-up visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Enoxaparin | Active comparator | Drug: Enoxaparin40 mg subcutaneous enoxaparin given once daily for DVT prevention. |
| Experimental: Apixaban | Experimental | Drug: Apixaban2.5 mg oral apixaban given twice daily for DVT prevention. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provide signed and dated informed consent.
- Be willing and able to comply with study procedures and follow-up.
- Be 18-89 years old (male or female).
- Have a negative pregnancy test within 24 hours before surgery (if woman of childbearing potential).
- Have biopsy-proven head and neck cancer, or a suspected cancer awaiting tissue diagnosis (can be confirmed by frozen section at surgery).
Key exclusion criteria (11 listed)
- Lack a tissue diagnosis of head and neck cancer during the study period.
- Have one of these conditions instead of eligible cancer: Benign disease; Primary thyroid cancer (lower VTE risk); Lymphoma (not primarily surgical); or Melanoma
- Fail to undergo definitive head and neck oncologic surgery (e.g., only diagnostic biopsy).
- Have surgery limited to tissue diagnosis only (e.g., direct laryngoscopy, excisional lymph node biopsy).
- Be unable (patient or caregiver) to administer the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoxaparinFor DVT prophylaxis | Drug | Control: Enoxaparin |
| ApixabanFor DVT prophylaxis | Drug | Experimental: Apixaban |
Primary outcome
Study enrollment rate.
Time frame: From study start until target enrollment is reached (up to 24 months).
Enrollment rate will be calculated as the number of participants enrolled, divided by the number of eligible participants, multiplied by 100%.
2 secondary outcomes
Medication satisfaction.
Time frame: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Medication satisfaction.
Time frame: Assessed at Day 11-14 after completing 10 days of anticoagulant prophylaxis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin and Apixaban in people with Venous Thromboembolism and Head and Neck Cancer, run by Kiranya Arnold at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laine Abernathy, MS (315-464-5980, abernatL@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study enrollment rate. (time frame: From study start until target enrollment is reached (up to 24 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.